Tandem Diabetes announces approval of IDE for trial
Tandem Diabetes Care announced the approval of an Investigational Device Exemption, or IDE, for its pivotal trial. The company also announced that it presented results from a feasibility study for its predictive low glucose suspend algorithm, designed to suspend insulin delivery when low blood sugar is predicted. "The results from this feasibility study are very encouraging. The IDE for our pivotal trial, which will use the predictive low glucose suspend algorithm on a t:slim X2(TM) Pump with Dexcom G5 Mobile CGM integration, was approved by the FDA in May, and we look forward to starting enrollment soon. Our goal remains to submit our t:slim X2 Pump with predictive low glucose suspend to the FDA later this year, and we continue to plan for launch of this product in early 2018, subject to FDA approval," said Kim Blickenstaff, president and CEO of Tandem.